1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Product name: Total Protein Gen.2Product number: 03183734190Business area: Centralized DiagnosticsProduct line: Integra, Cobas 6000

2. COMPOSITION/INFORMATION ON INGREDIENTS Description 1: Bottles 1a and 1b

Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:Sodium hydroxide 1310-73-2 1-5 2 mg/m3 NA NA 2 mg/m3 Ceiling

Sodium Potassium Tartrate 304-59-6 1-5 NA NA NA NA Description 2: Bottle 2

Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:Sodium hydroxide 1310-73-2 1-5 2 mg/m3 NA NA 2 mg/m3 Ceiling

Sodium Potassium Tartrate 304-59-6 1-5 NA NA NA NAPotassium Iodide 7861-11-0 0.1-<1 NA NA NA NA

3. HAZARDS IDENTIFICATION

Principle routes of exposure: Ingestion, inhalation, skin and/or eye contact. Inhalation: Avoid breathing vapors or mists. Irritating to respiratory system. Ingestion: Ingestion may cause nausea, vomiting, sore throat, stomach-ache and eventually lead to a perforation of

the intestine. Ingestion of larger amounts may cause defects to the central nervous system (e.g. dizziness, headache).

Skin contact: Moderately irritating to the skin. Eye contact: Avoid contact with eyes. Severe eye irritation. Contact may cause damage. Sensitization or Odor threshold: The following chemical(s) may cause sensitization, be absorbed via skin, and/or has an odor threshold for

detection: Medical conditions aggravated by exposure:

Persons with pre-existing skin disorders or impaired liver, kidney, and pulmonary function may be more susceptible to the effects of this material.

Additional information: None

4. FIRST AID MEASURES

Inhalation: Consult a physician. Move to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen

Skin contact: Rinse immediately with plenty of water for at least 15 minutes. If skin irritation persists, call a physician. Ingestion: Consult a physician. Do not induce vomiting without medical advice Eye contact: Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician.

Special Definitions: A=Allergen CA=Carcinogen CO=Corrosive F=Flammable H=Harmful I=Irritant Ox=Oxidizer PB=Potential Biohazard R=Reproductive S=Sensitizer T=Toxic T+=Highly Toxic W=Water Reactive

Material Safety Data Sheet

Supplier:Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250 Site Phone Number: 1-800-428-5074

Emergency telephone number:CHEMTREC: 1-800-424-9300 (U.S. or Canada) 1-703-527-3887 (International)

Emergency Overview

NFPA Ratings: Health= 3 Flammability= 0 Reactivity= 0 Special= CO

Revision date: 09/18/2009Print Date: 09/18/2009Version: 2

Notes to physician: None determined

5. FIRE-FIGHTING MEASURES

Suitable extinguishing media: Use dry chemical, CO2, water spray or `alcohol` foam Unusual hazards: None known Special protective equipment for firefighters:

Wear self contained breathing apparatus for fire fighting if necessary

6. ACCIDENTAL RELEASE MEASURES

Personal precautions: Use personal protective equipment. Evacuate personnel to safe areasEnvironmental precautions: Prevent further leakage or spillage if safe to do so. Prevent product from entering drains. Methods for cleaning up: Never return spills in original containers for re-use. Sweep up or vacuum (if powder) or soak up with inert

absorbent material (if liquid), then place into a suitable clean, dry, closed container, and label for disposal

7. HANDLING AND STORAGE

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Engineering measures: Not applicable Personal Protective Equipment Respiratory protection: Respiratory protection is not required under normal use of this product. If respiratory protection is needed,

follow the OSHA regulation, 29CFR1910.134. Always use a NIOSH approved respirator when necessary Hand protection: Wear appropriate protective gloves to prevent skin contact. Replace torn or punctured gloves promptly Skin and body protection: Wear appropriate body protection to prevent skin contact Eye protection: Wear appropriate eye protection to prevent eye contact Hygiene measures: Avoid contact with skin, eyes and clothing

9. PHYSICAL AND CHEMICAL PROPERTIES

pH: Bottles 1a and 1b = 13.4. Bottle 2 = 13.2.Physical state: Liquid. Solubility in water: Soluble.

10. STABILITY AND REACTIVITY

Stability: Stable under recommended storage conditionsPolymerization: Not applicableHazardous decomposition products: Carbon oxidesMaterials to avoid: Strong oxidising agents. Strong acids.

11. TOXICOLOGICAL INFORMATION

Components NIOSH - Selected LD50s and LC50s:

NIOSH Pocket Guide - Target Organs:

Sodium hydroxide =1350 mg/kg Dermal LD50 Rabbit eyes skin respiratory system 10mg/m3IDLH

Components NIOSH -

Selected LD50s and LC50s:NIOSH Pocket Guide -

Target Organs:Sodium hydroxide =1350 mg/kg Dermal LD50 Rabbit eyes skin respiratory system

10mg/m3IDLH

Product name: Total Protein Gen.2

Protect from contamination. Wear personal protective equipment

Product number: 03183734190 Page 2 of 4

Storage: Handling:

No special precautions required

Inhalation: No additional data availableSkin: No additional data availableOral: LD50/oral/rat = 500 mg/kg for sodium hydroxide. Mutagenic effects: No data is available on the product itselfReproductive toxicity: No data is available on the product itself

12. ECOLOGICAL INFORMATION

Bioaccumulation: Not determined Aquatic toxicity: Ec50/24h/daphnia=76 mg/l for sodium hydroxide. Ecotoxicity effects: No data is available on the product itself U.S. EPA, RCRA, CERCLA, SARA, or DGC information on persistent, bioaccumulative, and toxic chemicals (PBTs): The following chemicals are listed under the U.S. EPA regulations of RCRA, CERCLA, SARA, or DGC:

13. DISPOSAL CONSIDERATIONS

Waste from residues / unused products: Waste disposal must be in accordance with appropriate Federal, State, and local regulations. This product, if unaltered by use, may be disposed of by treatment at a permitted facility or as advised by your local hazardous waste regulatory authority. Residue from fires extinguished with this material may be hazardous

14. TRANSPORT INFORMATION

Is product hazardous to ship? Yes. Component(s) hazardous to ship: Bottles 1a, 1b, and 2 DOT Proper shipping name: Sodium hydroxide solution

ICAO/IATA Proper shipping name: Sodium hydroxide solution

15. REGULATORY INFORMATION

U.S. Regulations: U.S. CERCLA/SARA/TSCA Regulatory Information: The following chemicals are listed under the following TSCA/SARA/CERCLA lists. Refer to TSCA regulation if you need a definition for acronyms that may be shown in the TSCA Inventory field in the table below

Components CERCLA/SARA 302 RQ and TPQ

(40 CFR 355, App.A)

CERCLA/SARA 304 RQ

(40 CFR Table 302.4)

SARA 313 Emission reporting

TSCA Inventory

Sodium hydroxide =1000 lb final RQ PresentSodium Potassium Tartrate Present

Components CERCLA/SARA 302

RQ and TPQ (40 CFR 355, App.A)

CERCLA/SARA 304 RQ

(40 CFR Table 302.4)

SARA 313 Emission reporting

TSCA Inventory

Sodium hydroxide =1000 lb final RQ PresentSodium Potassium Tartrate Present

U.S. Clean Water Act (CWA)/ California Proposition 65:

The following chemicals are listed under the CWA and/or California Proposition 65:

Components Clean Water Act

Hazardous SubstancesClean Water Act

Priority PollutantsCalifornia Proposition 65

Sodium hydroxide Present

Product name: Total Protein Gen.2

Packing group: III

Subsidiary risk: Not applicable Packing group: III UN Number: UN 1824

UN Number: UN 1824

Hazard class: 8

Product number: 03183734190

Hazard class: 8

Page 3 of 4

Subsidiary risk: Not applicable

Components Clean Water Act Hazardous Substances

Clean Water Act Priority Pollutants

California Proposition 65

Sodium hydroxide Present Canadian Regulations:

This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations and the MSDS contains all the information required by the Controlled Products Regulations.

Components Canada - WHMIS: Classifications of Substances:Sodium hydroxide E

Sodium Potassium Tartrate Uncontrolled product according to WHMIS classification criteria

Components Canada - WHMIS: Classifications of Substances:Sodium hydroxide E

Sodium Potassium Tartrate Uncontrolled product according to WHMIS classification criteria

16. OTHER INFORMATION

Reason for revision: Not applicableReferences: NoneAdditional advice: NonePrepared by: Roche Diagnostics, Health & Safety Department, MSDS Contact: 317-521-7425 or 317-521-7505 The information, data and recommendations contained herein are based upon information believed by Roche Diagnostics Operations after reasonable investigation and research, to be accurate; however, Roche Diagnostics Operations does not warrant the accuracy of this information. All materials and mixtures may present unknown hazards and should be used with caution. When necessary or appropriate, independent opinions regarding the risk of handling or exposure should be obtained from trained professionals. Roche Diagnostics Operations disclaims any warranty against patent infringement and the implied warranties of merchantability and fitness for a particular purpose. Customer's sole and exclusive remedy shall be replacement of the product or return of the product and refund of the purchase price, at Roche Diagnostics Operations's option. In no case shall Roche Diagnostics Operations be liable for incidental or consequential damages, including lost profits.

End of Safety Data Sheet

Product name: Total Protein Gen.2

Product number: 03183734190 Page 4 of 4